2,731 results
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118ms
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Sources: EU EUDAMED, US FDA
ADVANCED MEDICAL MACHINE
FDA Adverse Event
Other
·ADVANCED MEDICAL PRODUCTS, INC.·Product code ISA·September 2, 1999
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
FDA Enforcement
Class II
·Terminated·ASI Medical, Inc.·December 25, 2013
DERMAGRAFT
FDA Adverse Event
Other
·ADVANCED BIOHEALING, INC·Product code MGR·October 16, 2008
REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·February 3, 2026
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·March 18, 2026
CORTRAK 2 NG/NI FEEDING TUBE, ELECTROMAGNETIC STYLET, ENFIT
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·June 19, 2025
DERMAGRAFT
FDA Adverse Event
Other
·ADVANCED BIOHEALING, INC·Product code MGR·October 16, 2008
DERMAGRAFT
FDA Adverse Event
Other
·ADVANCED BIOHEALING, INC·Product code MGR·October 16, 2008
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·February 4, 2026
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·March 26, 2026
CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·August 22, 2024
BALLARD MINI-BAL SAMPLING CATHETER 16 F
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code OYI·September 21, 2021
DERMAGRAFT
FDA Adverse Event
Other
·ADVANCED BIOHEALING, INC·Product code MGR·October 16, 2008
DELTAPAQ CERE 2MMX6CM
FDA Adverse Event
Malfunction
·REFER TO SECTION H10·Product code HCG·April 23, 2018
CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBES
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·March 17, 2026
REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·January 29, 2026
STYLET USED TO ASSESS PATENCY AND KINKING STOPPED IN THE BACK OF THE MOUTH.
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code BTR·December 16, 2021
INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KGC·March 30, 2026
REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·January 28, 2026
REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
FDA Adverse Event
Malfunction
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·January 27, 2026